Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus

Influenza Clinical Trial

Official title:

Evaluation of In Vitro Cross-Reactivity With Avian Influenza H5N1 Virus in Healthy Volunteers Vaccinated With a Prime Boost Regimen of Seasonal Influenza Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01044095
• Other study ID #: WRAIR1525
• Secondary ID: HSRRB No. A-1522
• Status: Completed
• Phase: N/A
• First received: January 6, 2010
• Last updated: July 22, 2013
• Start date: November 2009
• Est. completion date: June 2012

Study information

• Verified date: July 2013
• Source: Armed Forces Research Institute of Medical Sciences, Thailand
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This will be a randomized, open-label, pilot feasibility study of four 2-dose vaccine regimens in healthy volunteers using two commercially available seasonal influenza vaccines to compare immune responses and in vitro cross-reactivity against H5N1. Vaccine doses will be spaced by approximately 8 weeks to allow for optimal prime boost conditions. Humoral, cellular and secretory immune responses will be measured 2 and 4 weeks after each vaccine dose and compared with baseline values.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2012
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

1. Aged 18-49 years.

2. Healthy as determined by the PI or designate

3. Willing to give informed consent.

4. Willing to attend follow-up appointments and undergo study procedures.

5. US passport holder residing in Bangkok

6. If military, have a letter of approval for participation from the chain of command (Unit Commander).

Exclusion Criteria:

1. History of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine.

2. Severe or life-threatening reaction to any previous vaccine.

3. History of chronic respiratory illness, including asthma and sinusitis.

4. History of heart disease

5. History of kidney disease

6. Metabolic disease such as diabetes

7. Immunocompromised as determined by the PI, or a household contact of an immunocompromised individual.

8. History of Guillain-Barre syndrome.

9. Blood disease including sickle cell disease and/or bleeding tendency (by history or based on medical records).

10. Any influenza vaccination within the previous 6 months, or any other vaccine within 30 days of either dose of influenza vaccine.

11. Pregnant woman or nursing mother or unwilling to use reliable contraception during the study period until the final day of follow-up.

12. Blood donation within the preceding 3 months, or screening hemoglobin value of <12.5 g/dl.

13. Receipt of blood products including immunoglobulins within the preceding 3 months.

14. Receiving any of the following therapies: aspirin, warfarin, theophylline, phenytoin, aminopyrine, immunosuppressive drugs,

15. Receipt of any antiviral agents within 48 hours of vaccine administration.

16. HIV positive on screening blood tests.

17. Any other condition that in the opinion of the study investigator warrants exclusion from the study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• FluMist® live, attenuated, intranasal seasonal influenza vaccine
FluMist® live, attenuated, intranasal seasonal influenza vaccine 0.2mL (0.1mL per nostril)
• Fluzone® inactivated influenza virus vaccine
Fluzone® inactivated influenza virus vaccine 0.5mL intramuscularly

Locations

Country	Name	City	State
Thailand	United States Embassy Medical Unit	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Armed Forces Research Institute of Medical Sciences, Thailand

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Bethell D, Saunders D, Jongkaewwattana A, Kramyu J, Thitithayanont A, Wiboon-ut S, Yongvanitchit K, Limsalakpetch A, Kum-Arb U, Uthaimongkol N, Garcia JM, Timmermans AE, Peiris M, Thomas S, Engering A, Jarman RG, Mongkolsirichaikul D, Mason C, Khemnu N, T — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	antibody titers		12 weeks	No
Secondary	safety of 2 doses of seasonal influenza vaccine in healthy adults		12 weeks	Yes

External Links

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